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Rationale for Evaluating Ceritinib in ALK-Positive Patients With NSCLC

Laura Quan Man Chow, MD, FRCPC
Published Online:8:22 PM, Mon November 4, 2019

Laura Quan Man Chow, MD, FRCPC, director of the Thoracic, Head and Neck Cancer, and Clinical Immunotherapy Programs, and associate cancer center director for clinical research, The University of Texas at Austin, discusses the rationale for evaluating ceritinib (Zykadia) in patients with ALK-positive non–small cell lung cancer (NSCLC) in the ASCEND-7 trial.

This phase II clinical trial was 1 of the first studies dedicated to investigating the activity of a targeted agent in the brain, as well as to measure and assess the brain activity, says Chow. It is particularly common for patients with ALK-positive patients with NSCLC to experience progression in the brain and develop brain metastases overtime. When the ALK tyrosine kinase inhibitors were first developed, investigators noted great activity with crizotinib (Xalkori), for example, but progression still tended to occur in these patients due to an acquired resistance.

When ceritinib was developed, responses were documented in the brain during the first phase I clinical trials. Intracranial responses by neuroradiology were noted and ceritinib was found to be active in the ASCEND-3, -4, and -5 clinical trials. Prior to evaluating this agent in the ASCEND-7 trial, investigators knew this agent had a high response rate in the brain and that it could also penetrate the blood-brain barrier to elicit responses.
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